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Real-Time Near-infrared (NIR) Mapping of Sentinel Lymph Nodes in Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
John V. Frangioni, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01468649
First received: June 30, 2011
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imaging.

Condition Intervention Phase
Breast Cancer Device: NIR Imaging with FLARE and Mini-FLARE Imaging System Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer

Resource links provided by NLM:


Further study details as provided by John V. Frangioni, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Sensitivity of Real-Time Intraoperative NIR Mapping [ Time Frame: One Day (day 1) ]
    To determine the sensitivity of real-time intraoperative NIR lymphatic mapping in the identification of the sentinel lymph node in human breast cancer as compared to the standard of care, Technicium 99 (Tc-99).


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: One Day (day 1) ]
    To evaluate the incidence of significant adverse reactions due to both NIR lymphatic mapping and indocyanine green.


Enrollment: 50
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast Cancer SLN Mapping
Fifty participants consented who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
Device: NIR Imaging with FLARE and Mini-FLARE Imaging System
A custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the injected dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location.
Other Name: Fluorescence assisted imaging

Detailed Description:

Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.

Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the time of SLN mapping, the patient will be injected with indocyanine green dye (ICG). Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location. The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm the radioactivity and NIR fluorescence signal in each after resection.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have histologically confirmed breast cancer and be deemed an appropriate surgical candidate with consent for a sentinel lymph node mapping by their oncologic surgeon.
  • Age minimum: 18 years.
  • Participant must be receiving a planned lymphoscintigraphy procedure.
  • Participant must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who choose not to proceed with sentinel lymph node biopsy.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy.
  • Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468649

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: John V. Frangioni, M.D., Ph.D. Beth Israel Deaconess Medical Center
  More Information

Responsible Party: John V. Frangioni, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01468649     History of Changes
Other Study ID Numbers: 2007P000431
Study First Received: June 30, 2011
Last Updated: March 3, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John V. Frangioni, Beth Israel Deaconess Medical Center:
Breast Cancer
Sentinel Lymph Node Mapping
Intraoperative Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2017